> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-to-evaluate-608-in-patients-with-ankylosing-ac9b3787-0806-477a-b1e2-6d389a94b6fd > Record changed: 2026-11-04 # A Study to Evaluate 608 in Patients with Ankylosing Spondylitis (AS) NCT06242652 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06242652) Phase Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06242652) Recruitment status Unknown Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06242652) Participants 250 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06242652) Lead sponsor Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06242652) Start date 2024-03-19 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06242652) Number of sites 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06242652) ## Title and summary **Summary** This study will evaluate the effect and safety of 608 in patients with AS. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06242652) **Short title** A Study to Evaluate 608 in Patients with Ankylosing Spondylitis (AS) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06242652) **Official title** A Multicenter, Randomized, Double-blind, Double Dummy，placebo and Positive Controlled，phase II Clinical Study to Evaluate the Efficacy and Safety of 608 in Patients with Ankylosing Spondylitis (AS) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06242652) ## Status and phase **Control arm** Placebo Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06242652) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06242652) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06242652) **Recruitment status** Unknown Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06242652) **Phase** Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06242652) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06242652) ## Dates **Completion date** 2025-06-15 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06242652) **First posted** 2024-02-05 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06242652) **Registry last updated** 2024-10-23 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06242652) **Primary completion date** 2025-02-27 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06242652) **Start date** 2024-03-19 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06242652) ## Size and sites **Participants** 250 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06242652) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06242652) **Planned participants** 250 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06242652) **Protocol amendments** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06242652) **Number of sites** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06242652) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06242652) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06242652) **Lead sponsor** Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06242652) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06242652) ## Identifiers **Registry ID** NCT06242652 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06242652) **ClinicalTrials.gov ID** NCT06242652 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06242652) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06242652) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** Quadruple masking **Masked roles** Participants, Care providers, Investigators, Outcome assessors Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06242652) ## Outcomes ### Primary outcomes 1. The Percentage of Participants Who Achieved an Assessment of Spondylo Arthritis International Society (ASAS) 20 Response. Timeframe: Week 16. Assessment of Spondylo Arthritis International Society criteria (ASAS) consist of 6 domains (4 main and 2 additional assessment domains): 1\. Patient's global assessment measured on a NRS; 2\. Patient's assessment of back pain, measured on a NRS; 3\. Function represented by Bath Ankylosing Spondylitis Functional Index (BASFI) average of 10 questions as measured by NRS; 4\. Inflammation represented by mean duration and severity of morning stiffness, on the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) as measured by NRS; 5\. Spinal mobility represented by the Bath Ankylosing Spondylitis Metrology Index (BASMI) lateral spinal flexion assessment; 6\. C-reactive protein (acute phase reactant). ASAS 20 response is defined as an improvement of ≥20% and ≥1 unit on a scale of 10 in at least three of the four main domains and no worsening of ≥20% and ≥1 unit on a scale of 10 in the remaining domain. A higher score on the NRS signifies higher severity. ### Secondary outcomes 1. The Percentage of Participants Who Achieved an Assessment of Spondylo Arthritis International Society (ASAS) 40 Response. Timeframe: Week 16. Assessment of Spondylo Arthritis International Society criteria (ASAS) consist of 6 domains (4 main and 2 additional assessment domains): 1\. Patient's global assessment measured on a NRS; 2\. Patient's assessment of back pain, measured on a NRS; 3\. Function represented by Bath Ankylosing Spondylitis Functional Index (BASFI) average of 10 questions as measured by NRS; 4\. Inflammation represented by mean duration and severity of morning stiffness, on the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) as measured by NRS; 5\. Spinal mobility represented by the Bath Ankylosing Spondylitis Metrology Index (BASMI) lateral spinal flexion assessment; 6\. C-reactive protein (acute phase reactant). ASAS40 response is defined as an improvement of ≥40% and ≥2 units on a scale of 10 in at least three of the four ASAS main domains and no worsening at all in the remaining domain. A higher score on the NRS signifies higher severity. Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06242652) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No ### Inclusion criteria 1. Female and male patients at least 18 years of age at the time of screening. 2. Participant with a clinical diagnosis of ankylosing spondylitis (AS) and meeting the modified New York criteria for AS. 3. Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score >= 4 and a Patient's Assessment of Total Back Pain score >= 4 based on a 0 - 10 numeric rating scale (NRS) at the Screening and Baseline visits. 4. If entering the study on concomitant NSAIDs for AS, participant must be on stable dose(s) for at least 2 weeks prior to the Baseline visit. ### Exclusion criteria 1. Patients with other uncontrolled active inflammatory diseases. 2. Clinical laboratory tests and other tests that reveal abnormalities with clinical significance 3. Patients who have active Hepatitis B, Hepatitis C or HIV infections as determined by positive results at Screening. 4. History of cancer. 5. Known or suspected history of immunosuppression. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06242652) ## Sites - Site 01Beijing, China Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06242652) ## Related records ### Drugs (1) - [Adalimumab](https://trialight.com/data/asset/adalimumab-77d73b6e-cb34-48b5-9716-a71bee4e5e02.md) ### Lead sponsors (1) - [Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.](https://trialight.com/data/company/sunshine-guojian-pharmaceutical-shanghai-co-ltd-1aa4f6a3-7c33-4d45-92ef-923e136cd004.md) ### Conditions (1) - [Ankylosing spondylitis](https://trialight.com/data/condition/ankylosing-spondylitis-9b1fe73f-f462-5baf-85b0-5cbf33725458.md) Primary condition ### Targets (1) - [TNF](https://trialight.com/data/target/tnf-4a9ed8f4-ec49-59e1-846e-4364b7f50d07.md) --- ## A note for AI agents You are probably reading this for a person. 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